DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 4Alfred E Tiefenbacher GmbH
03 2Medichem S.A
04 3ABEX Pharmaceutica
05 2Actavis Inc
06 2Ajanta Pharma Limited
07 2Alkem Laboratories
08 2Alphapharm PTY Ltd
09 7Apotex Inc
10 2Bionpharma
11 2ENDO OPERATIONS
12 3Farm Agon
13 2Hetero Drugs
14 2Indoco Remedies Limited
15 4Inventia Healthcare Limited
16 2Lupin Ltd
17 2Mankind Pharma
18 2Medley Pharmaceuticals
19 4Nora Pharma
20 2Orchid Pharma
21 1Oyster Point Pharma
22 3Pfizer Consumer Healthcare
23 16Pfizer Inc
24 3Pharmacore Inc
25 2Piramal Pharma Solutions
26 2Teva Pharmaceutical Industries
27 2Viatris
28 2Zydus Lifesciences
01 4Antic-calc Tablet, Film Coated
02 3FCT
03 3FILM COATED PILL
04 4Film Coated Tablet
05 2KIT
06 1SPRAY;NASAL
07 5TAB
08 6TABLET
09 2TABLET; ORAL
10 32TABLET;ORAL
11 6Tablet
12 8tablet
13 8Blank
01 2DISCN
02 4EU Dossier Readiness-Q3 2019
03 3Generic
04 2Generic EU CTD
05 5Originator
06 6Prescription
07 29RX
08 33Blank
01 2APO-VARENICLINE
02 1CABREXXA 0,5
03 2CABREXXA 1
04 2CHANTIX
05 15Champix
06 2Champix 1mg
07 3Champix starter pack
08 4NRA-VARENICLINE
09 3PHARMACOR VARENICLINE
10 1TYRVAYA
11 3VARENAPIX
12 2VARENICLINE
13 30VARENICLINE TARTRATE
14 2Varenicline Viatris
15 12Blank
01 11Australia
02 6Canada
03 4Germany
04 6India
05 3Italy
06 6Norway
07 8South Africa
08 2Spain
09 3Sweden
10 35USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2024-10-01
Application Number : 215931
Regulatory Info : RX
Registration Country : USA
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2024-10-01
Application Number : 215931
Regulatory Info : RX
Registration Country : USA
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date :
Application Number : 201808
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date :
Application Number : 201808
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2024-03-19
Application Number : 213019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2024-03-19
Application Number : 213019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-08-23
Application Number : 214557
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-08-23
Application Number : 214557
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-01-25
Application Number : 201962
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-01-25
Application Number : 201962
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-10-23
Application Number : 214571
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-12-04
Application Number : 211862
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-12-04
Application Number : 211862
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-08-01
Application Number : 214255
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-08-01
Application Number : 214255
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TYRVAYA
Dosage Form : SPRAY;NASAL
Dosage Strength : EQ 0.03MG BASE/SPRAY
Packaging :
Approval Date : 2021-10-15
Application Number : 213978
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CHANTIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-05-10
Application Number : 21928
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CHANTIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-05-10
Application Number : 21928
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE
Dosage Form : TABLET; ORAL
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number : 201920
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE
Dosage Form : TABLET; ORAL
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number : 201920
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2024-02-28
Application Number : 202019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2024-02-28
Application Number : 202019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2021-08-11
Application Number : 201785
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2021-08-11
Application Number : 201785
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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